Clearly Communicating Research Results across the Clinical Trials Continuum

Introduction

The NIH’s mission is “to improve health and reduce the burdens of disease and disability.” And, along with the legions of volunteers who participate in clinical research, the NIH and the Nation rely on clinical research scientists to fulfill that essential mission. For people who are sick, injured, or who have a disability, clinical trials may provide life-changing treatments and or strategies for them. Or, clinical trials may be a step toward preventing, treating, easing or curing disease in the future. When clinical trials successfully recruit and retain participants from all backgrounds who become full partners in the process, science moves forward and we can all achieve better health.

Respect for potential and enrolled participants is a fundamental principle[1]. Researchers know about this and other requirements and responsibilities of clinical research with human subjects[2]. But it is critical that scientists also become knowledgeable about how to reach and communicate in their communities before, during and after a trial. Educating the public about clinical research may help raise general awareness about the important role this research plays in safeguarding health and quality of life, but these efforts are only the beginning.

Key to encouraging public support for and participation in clinical research is trust, and researchers must take the time and make the effort to build that trust. Communicating directly with participants as they join a study — and throughout the process — is critical to earning and maintaining trust. This includes explaining kindly and carefully why someone is not eligible to participate in a specific study.

Researchers also need to develop meaningful relationships in the communities from which they hope to recruit participants. Every community is different. Individuals or communities considering taking part in a clinical study often want to participate in the entire process, from the study design to dissemination of results. Engaging the community[3] from the earliest phases of clinical research can strengthen the process and help ensure that a trial runs smoothly and efficiently.

Criteria for Pre-Recruitment Planning

Before even initially contacting individuals, organizations and agencies, pre-planning your outreach and setting up policies and procedures will help ensure thoughtful recruitment and retention[4] of participants. Outreach efforts should be respectful and build a sense of partnership. Laying out communication interactions and creating timelines before the recruitment begins may save time and effort and build better working relationships. This gives the research team, as well as potential participants, a map for how recruitment, retention and reporting of results will proceed.

Consider the needs of the study participants.

Choose only protocol staff members to interact with potential participants who exhibit and practice cultural respect to ensure that participants are valued and empowered in the process. The scientific criteria for selecting individuals who are eligible and appropriate for enrollment in a study have been carefully considered. It is equally important, at the same time, to pay serious attention to other factors, such as:

Who are potential participants (e.g., women, diverse communities, children and families, older adults, people who have mental or physical disabilities, etc.) and what specific requirements might they have to participate in the study?

What benefits and motivators are there to encourage participation? How will this study benefit the participants or others?

What barriers and obstacles will potential participants need to overcome (e.g., invasive procedures, time of visits, transportation, language differences, unfamiliarity or mistrust, competing trials, etc.)? How can you help them?

Are there logistical adjustments you can make to the protocol or clinic operations to make it as easy as possible to participate? (e.g., weekend hours, use of in-home technology or mobile monitoring, etc.)

Will you provide appropriate incentives, such as transportation, gifts cards, or childcare?

Engage the community.

Once you have identified the community you will recruit from, think about how you might reach members of the community who could potentially participate in the study. Long-term relationships with communities require an ongoing commitment before, during and after the trial. Factors to consider include:

What current relationships and level of trust do you have within the community? Are these ongoing, or do they need to be established?

How does this study meet the priorities of the community? Is there a way to align the goals of the study with and the needs of the community?

How will you ask for and incorporate community input into the study?

Will you need to plan for native speakers to interpret the language of the community? This shows respect and interest in community engagement!

Have you considered how you may be able to contribute continuously to the community (such as participation in a health fair, sharing plans and presenting research results directly with the community, etc.)?

Plan messaging and informational materials.

Make sure your outreach and messages are culturally respectful and meaningful. They should be based on the needs of the study population and with input from the community. Ask yourself:

Who may be in the best position to deliver messages that connect with and build trust within the community? Is it the principal investigator/clinician or staff from the study community?

What are the best channels to deliver messages to your study population: Social media? Traditional media? Mobile channels? Mail? In-person events? Via advocacy organizations or other intermediaries?

Think about the following logistical and administrative factors:

How will you respond to the questions and needs of potential participants? Are you prepared for phone/email inquiries? Initial screenings?

Will this community have access to computers, mobile devices, telephones? If not, alternative approaches will need to be considered.

How will people receive timely responses, and will this affect staff scheduling? What is a timely response? How will you communicate the response time (e.g. 2 days, by email, 48 hours)? Establish a standard and let the participants know what to expect.

How will you communicate the limitations for participation to a volunteer?

How will you handle volunteers who do not qualify for the trial? Is there a local registry? Is there another research study they may be eligible for?

Remember to thank them for offering to participate. It is CRITICAL that study participants be engaged throughout the entire study and that this interaction is ongoing.

Recruitment

Although there is overlap between pre-recruitment and recruitment, this phase could be your first interaction with a participant, so it is important to engage and empower them from the first correspondence or encounter. This rapport will set the foundation for effective communication between you and the individuals you seek to enroll. Think about communications strategies[5] that will help you reach the communities and participants you’re seeking. For example, many people think of “research” as including only clinical trials testing experimental drugs; they may be unaware that there are many types of studies involving different time commitments.

Attracting Participants

What recruitment methods will you use to ensure you reach and capture potential participant(s)?

Will it be through community engagement, one-on-one, or in combination? This might include talks to community groups, town meetings, informational materials for participants to take home to read and consider in multiple languages if needed.

What has been effective in the past? Have you reviewed data from similar studies to identify what recruitment strategies are preferred and effective to reach participants?

Screening Participants

What type of participant profile are you seeking, and why?

Explain to prospective participants the profile of the ideal study candidates you are seeking and, most importantly, why.

Describe the study’s objectives, and why their participation matters.

Identifying and Engaging Participants

How can you make potential subjects feel valued and empowered in the process, starting with the recruitment phase?

Have you explained what type of research this is (e.g., clinical trial to test a new therapy, behavioral research, a survey)?

Have you explained the overall goals of the study and described to the potential participant why his/her involvement is significant? Have you explained in detail their rights as a participant?

Do they know how they will be contacted and with what frequency?

Do they know how to reach the research staff should they have any questions/concerns?

Enrollment

As individuals consider enrolling in the study, provide a complete discussion on what is involved in participating in the trial. This is not only to obtain consent, but to enhance understanding, what will happen along the way, and the individual’s role. Does the consent document include any information about the study that a reasonable person would want to know?

Explain risks and benefits in clear terms. Provide a balanced approach when describing the risks and benefits of participating in the study.

What kinds of tests will the participant undergo? What samples will be obtained and what are the procedures for doing so? How often? Why?

Explain and emphasize that data security and privacy standards will be carefully followed in the study. This is a huge concern of many potential participants.

Encourage participants to ask questions. Wait for a response.

Make sure participants understand the logistics and any costs of participating in the study. Are there any tests and/or medications a participant might be responsible for paying, and what charges may or may not be covered by insurance?

Retention

Continuous communication throughout the clinical trial process is essential for retention.

Meet with volunteers at their first appointment to give them a packet of information. Provide contact phone numbers, a copy of their informed consent, and their visit schedule for the entire trial, so participants can plan accordingly. This will decrease the no-show rate.

Research staff should maintain consistent contact — by email, postcards or phone calls — with study participants for the duration of the trial.

Schedule updates for contacting participants about progress.

Let them know how you will contact them.

As before, encourage questions.

Protect privacy, and enforce ethical standards.

End of Study

You are really done twice. The first ending marker, for you and for the participants, is when data collection is complete. This is a time to thank participants for all that they have done. You will also want to promise to communicate the results of the study and in what expected timeframe.

Keeping participants informed about research findings is as important as gathering the data. Participants often cite their contribution to future medical discovery as the reason for their participation. A national survey found that the general public and particularly minority groups cited altruism as a key reason to participate in a clinical trial. The study revealed that “nearly half of African-Americans, Asians and Hispanics say they greatly admire individuals who volunteer for clinical trials, compared to 35% of non-Hispanic whites.”[8]

Principal investigators should establish a plan for informing participants about research results, by sharing published studies, or when possible, news releases, which are written in consumer-friendly language. According to The Center for Information and Study on Clinical Research Participation (CISCRP) almost all patients want to know the results of their trial yet almost no patients are being told their trial’s results[9].

Researchers should assure participants that the line of communication is open and provide a contact email address. Consider making sure that all the explanations or links to study results are prefaced by a clearly written summary that puts the information in context for the reader (Getting Started or Brushing Up[10]).

Inform participants about how they can look for published study results. Clinical trial reports published in peer-reviewed scientific journals are searchable through the National Library of Medicine’s PubMed database and the National Institutes of Health registry clinicaltrials.gov. Provide participants with the study’s official name or Protocol ID number so they may search the database. In addition, provide participants with the research team contact information should they have follow-up questions.

After the Study is Published

When the study first becomes available in its entirety through public access, send participants a note and a link. Share other research papers that are published as a result of analyzing the data. The NIH Public Access Policy ensures that the public has free access within a year to the published results of NIH-funded research.It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central. To advance science and improve human health, NIH makes the peer-reviewed articles it funds publicly available on PubMed Central. The NIH public access policy requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central immediately upon acceptance for publication.

Comments often made by people dissatisfied with having participated in research focus on the lack of communication about the results. The participants want to know what you found. In turn, if their experience is good or bad they will share it broadly, often within communities. Informing participants about the published research results models both gratitude and provides them with the substantial addition of information pertaining to their disease or condition. It also helps to provide participants with a good experience that they will share with family, friends and their community.